Drug updated on 11/1/2024
Dosage Form | Injection (intravenous: 35 mcg) |
Drug Class | Bispecific CD19-directed CD3 T-cell engagers |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adults and pediatric patients one month and older with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%
- Indicated for the treatment of adults and pediatric patients one month and older with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL)
- Indicated for the treatment of adults and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute
- lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy.
Latest News
Summary
- This summary is based on the review of 11 systematic review(s)/meta-analysis(es). [1-11]
- Ph+ ALL Treatment Outcomes: In patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), the three-agent regimen combining TKI (tyrosine kinase inhibitor), blinatumomab, and steroids achieved a pooled complete molecular response (CMR) rate of 81% (95% CI (confidence interval): 69%-89%), with a nearly 6-fold increased likelihood of CMR compared to TKI alone (OR (odds ratio): 5.98; 95% CI: 2.99-11.96) and a 5-fold increase in 1-year survival (OR: 5.1; 95% CI: 1.74-14.9).
- Pediatric R/R B-ALL: In relapsed/refractory (R/R) B-ALL (B cell acute lymphoblastic leukemia) among pediatric patients, single-arm studies showed a complete remission (CR) rate of 0.56 (95% CI: 0.45-0.68) and an overall survival (OS) rate of 0.43 (95% CI: 0.32-0.54). In randomized controlled trials (RCTs), blinatumomab compared to chemotherapy improved OS (0.12; 95% CI: 0.05-0.19) and event-free survival (EFS) rates (2.16; 95% CI: 1.54-3.03).
- R/R B-ALL and NHL Responses: In relapsed/refractory B-ALL and non-Hodgkin lymphoma (NHL), the pooled CR rate for ALL was 0.45 (95% CI: 0.37-0.53), with higher CR observed in patients with bone marrow blasts below 50% (0.75) compared to those with blasts at or above 50% (0.33).
- Adult R/R BCP ALL: In adult R/R B-cell precursor (BCP) ALL, first salvage treatment resulted in a longer median OS (10.4 months) compared to second or later salvage (5.7 months; HR: 1.58; 95% CI: 1.26-1.97) and a higher remission rate (54% vs. 41%).
- Adverse Events in Pediatric R/R B-ALL: In single-arm studies, the adverse event (AE) rate was 0.65 (95% CI: 0.54-0.76), with Grade ≥3 AEs observed in 80% (95% CI: 72%-88%), including Grade ≥3 neurological toxicity at 7% (95% CI: 4%-11%) and cytokine release syndrome (CRS) at 3% (95% CI: 2%-5%).
- Comparison to Chemotherapy in Pediatric B-ALL: Blinatumomab was associated with a lower risk of serious AEs (RR: 0.56; 95% CI: 0.32-0.99), febrile neutropenia (RR: 0.13; 95% CI: 0.06-0.26), and infection (RR: 0.40; 95% CI: 0.29-0.56) compared to chemotherapy, though the risk of encephalopathy was higher (RR: 8.90; 95% CI: 1.08-73.29).
- Safety in R/R BCP ALL During Salvage Treatment: Higher frequencies of cytokine release syndrome, febrile neutropenia, and infection were observed in patients undergoing second or later salvage treatments compared to first salvage.
- Higher effectiveness was observed in Ph+ ALL patients treated with TKIs, blinatumomab, and steroids, particularly with ponatinib over dasatinib. In pediatric R/R B-ALL, CR rates were greater in patients with bone marrow blasts below 50%. Adult R/R BCP ALL showed improved outcomes with first salvage treatment compared to later salvage, and ALL patients had better response rates than NHL patients, with reduced tumor load further supporting clinical response in ALL.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Blincyto (blinatumomab) Prescribing Information. | 2024 | Amgen Inc., Thousand Oaks, California |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
ESMO Clinical Practice Guideline interim update on the use of targeted therapy in acute lymphoblastic leukaemia. | 2023 | Annals of Oncology |
Acute lymphoblastic leukemia in adults. | 2022 | Alberta Health Services |
Acute Lymphoblastic Leukemia, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology. | 2021 | Journal of the National Comprehensive Cancer Network |
The Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of acute leukemia. | 2020 | Journal for Immunotherapy of Cancer |